Decreased granulomatous reaction by polyurethane-coated stent in the trachea.

Background: Reducing granulomatous reaction for stent implantation is important for the treatment of tracheobronchomalacia because formation of granuloma leads to refractory complication causing further respiratory distress. The purpose of this study was to clarify granulomatous reaction of newly innovated coated stents compared to non-coated metal stents.

Methods: Materials and animal experiments were performed using the newly invented metallic stent (laser-cut stainless steel with a coating of polyurethane). In the materials experiment, the correlation between the holding force and deformity was tested by a compressor. In the animal examination, coated stents were orally implanted into the trachea in five rabbits, while non-coated stents were implanted in another five rabbits. After 3 weeks' observation, the inner diameter was measured by 3-D computed tomography, and the number of granulation tissues was counted by bronchofiberscope. Histological investigation followed in both groups.

Results: In the materials experiment, new stents demonstrated a holding force similar to stainless steel stents. In the animal experiment, no difference was found in the inner diameter of the coated and non-coated stent groups (5.70 ± 0.17 vs 5.60 ± 0.27, P = 0.07). However, the number of granulation tissues was higher in non-coated stents than in coated stents (1.60 ± 0.55 vs 0.40 ± 0.55, P < 0.01). Histological investigation showed direct attachment of metal to the tracheal wall around the non-coated stents where epithelial structure was destroyed, while tracheal epithelia were preserved in the group of coated stents.

Conclusions: The new polyurethane-coated metallic stent maintains enough holding force, and reduces histobiological reaction to foreign bodies in this experiment.